Arthrosurface Receives FDA Clearance for BOSS™ Toe Fixation System
New joint preserving implant compatible with the Toe HemiCAP DF® and ToeMotion™ Systems
FRANKLIN, Mass., Sept. 5, 2019 /PRNewswire/ -- Arthrosurface®, Inc., a global leader in joint preservation technology, recently received 510K clearance from the FDA for its BOSS™ Toe Fixation System. This new product is intended to improve stabilization in a first metatarsal that presents with a distal bone void and provides patients with a motion-preserving alternative to toe fusion.
"Finally there is an option other than fusion for failed synthetic implants," said Carl Hasselman, MD, orthopedic surgeon with UPMC in Pennsylvania. "We can preserve motion of the joint, even in these difficult cases where there is a defect or void in the bone."
Osteoarthritis of the first metatarsalphalangeal (MTP) Joint, also known as Hallux Rigidus, affects one in 45 people in the US. Both surgeons and patients alike are searching for long-term solutions that provide pain relief while also preserving the natural motion of the foot. Arthrosurface® specifically engineered the BOSS™ Toe Fixation System to fill the current void of treatment options available for failed synthetic implants. It is designed for patients who want to avoid joint fusion and regain their motion and active lifestyles.
"We developed this device so we could meet the healthcare needs of our patients. Many experienced adverse effects from other toe implants or fusion plate systems. After much research and the gathering of qualitative data, we are confident in the future success of this device to fulfill patients' needs," stated Michael Downey, DPM, AACFAS and Gregory Jaryga, DPM, foot and ankle surgeons with Trinity Foot & Ankle Specialists in Texas.
The BOSS™ Toe Fixation System is used in conjunction with Arthrosurface's existing line of HemiCAP DF® implants and ToeMotion™ Systems. It offers immediate rigid fixation in cases with metaphyseal bone loss and is designed to stabilize the joint while also maintaining the length and mechanical axis of the toe.
The BOSS™ Toe Fixation System will be unveiled at the Arthrosurface Booth, #130, during the American Orthopaedic Foot & Ankle Society (AOFAS) Annual Meeting September 12-15 in Chicago and the product will be available at the end of September. For more information, click here.
The Arthrosurface® Toe Implant systems have been available since 2005 and 10-year follow-up data can be viewed here.
About Arthrosurface®, Inc.
Arthrosurface®, Inc. is a global leader in joint preservation technology, manufacturing less invasive joint replacements that are clinically proven to help patients stay active by increasing range of motion and reducing pain. The company's product portfolio features more than 150 different surface implant curvatures for the knee, shoulder, hip, ankle, wrist and toe that are designed to treat upper and lower extremity orthopedic conditions caused by trauma, injury and arthritic disease. More than 100,000 patients have been treated with Arthrosurface implants since the company was founded in 2002. Arthrosurface markets and distributes its products in the United States and around the world, with more than 5,000 surgeons currently using Arthrosurface products in more than 25 countries. For more information, please visit our website at www.arthrosurface.com.
SOURCE Arthrosurface, Inc.
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